After 15 years as head of the FDA’s Center for Devices and Radiological Health, Jeff Shuren, M.D., is retiring.
It’s a decision that comes after 28 years in government, which has included representing the agency in the U.S. Senate and at the National Institutes of Health and also serving in the Centers for Medicare and Medicaid Services to help oversee its coverage of medical devices and other products.
More recently, of course, Shuren was at the helm as COVID-19 brought a tidal wave of submissions into CDRH, as developers raced to provide everything from coronavirus tests to ventilators during the public health emergency.
Shuren’s retirement was announced during an all-hands meeting, as well as in an email to agency staff from FDA Commissioner Robert Califf, M.D., this week.
Starting July 28, the position of interim director will be taken over by Michelle Tarver, CDRH’s chief transformation officer, while Shuren is expected to stay on for a time in an emeritus advisor role during the transition.
During his time, CDRH launched new regulatory initiatives such as its breakthrough devices program and a digital health center of excellence, as well as establishing the agency’s stance toward artificial intelligence-powered devices, all in response to a rapidly evolving technological landscape.
In addition, the FDA recently said it would take a new approach to its oversight of laboratory-developed tests, bringing them more in line with how the agency evaluates other in vitro diagnostics and medical devices. That plan is being challenged in court by the clinical lab industry.
“On behalf of the entire medtech industry, I want to thank Dr. Shuren for his incredible career of service to patients and public health,” AdvaMed President and CEO Scott Whitaker said in a statement.
“Jeff understood the critical role a regulator plays in the innovation ecosystem, knowing how to balance the ultimate goal of medical device safety and effectiveness with the important goal of spurring innovations that improve and save lives. He saw AdvaMed and the medtech industry we represent as partners in addressing patients’ needs, and we hope his leadership serves as a model for all future directors of the CDRH,” Whitaker said.
“We look forward to working with Dr. Michelle Tarver as Interim Director to ensure the transition to new leadership is smooth, and that Dr. Shuren’s vision of a true public-private partnership remains the hallmark of the Center he helped establish as the gold standard for medical device safety worldwide.”
According to Shuren, he had begun considering retirement more than four years ago, but the pandemic pushed back his decision to depart.
He said the time is now, in part because COVID-19 is largely in the rear-view mirror, but also because of the agency’s lull between negotiations for its Medical Device User Fee Amendments. Shuren aims for new leadership to take point in the upcoming negotiations for the congressional legislation’s sixth iteration, set to take effect in late 2027.
Your correspondent moderated a panel featuring CDRH’s Tarver and other industry leaders earlier this year, examining medtech trends at the Milken Institute’s Global Conference in Los Angeles.